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Trial registered on ANZCTR
Registration number
ACTRN12608000622303
Ethics application status
Approved
Date submitted
16/10/2008
Date registered
8/12/2008
Date last updated
5/09/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms
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Scientific title
A randomised placebo-controlled trial of a herbal preparation in functional dyspepsia: cost effectiveness and mechanisms
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Secondary ID [1]
281173
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None
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Universal Trial Number (UTN)
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Trial acronym
FD study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Functional Gastrointestinal Disorders
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Condition category
Condition code
Oral and Gastrointestinal
3951
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study is designed to compare the effects of 4 different intervention groups with a double dummy technique. Intervention group 1: Iberogast, herbal medication, 20 drops orally 3 times a day for 4 week. Intervention group 2: Esomeprazole, Proton Pump Inhibitor (PPI), 20mg orally daily for 4 weeks. Intervention group 3:Oral Esomeprazole 20mg daily and oral Iberogast 20 drops 3 times a day for 4 weeks. Intervention group 4: oral placebo tablet daily and oral placebo liquid 20 drops 3 times a day for 4 weeks. All Responders to the treatments will continue with intervention group 4 (placebo) for week 6 and week 8. All intervention groups will have Endoscopy with biopsies, pregnancy urine test and Laboratory values only at screening. Questionnaires, nutrients challenge drink and blood for immune activation will be obtained at visits
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Intervention code [1]
3490
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Treatment: Other
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Comparator / control treatment
Placebo sugar pill will be pink in colour and administered once daily for 4 weeks and an additional 4 weeks if patients are considered responders. Liquid placebo will contain 28-34% ethanol, herbal and liquorice flavours similar taste to active herbal medication.
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Control group
Active
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Outcomes
Primary outcome [1]
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Cost- effectiveness will be assessed with a questionnaire regarding their on going costs relating to Irritable Bowel Symptoms or Functional Dyspesia whilst study participation.
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Assessment method [1]
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Timepoint [1]
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This assessment will be conducted at week 0, week 2, week 4 and if identified as responders week 6 and week 8.
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Primary outcome [2]
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Validated questionnnaires such as Leeds Dyspepsia Questionnaire (LDQ), Gastointestinal Syptoms (GIS), Hospital Anxiety and Depression scale (HADS) and Nepean Dyspepsia Index (NDI) will be used. Nutrients challenge drink and bloods immune activation will assist in clinical efficacy.
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Assessment method [2]
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Timepoint [2]
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After screening the study will be conducted from Baseline until completion in 4 weeks. If patients are identified as responders the trial will continue for these patient for an additional 4 weeks.
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Secondary outcome [1]
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The association between the clinical response (complete resolution or substantial improvement of symptoms) and changes of visceral sencory function before and during treatment as assessed with a nutrient challenge
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Assessment method [1]
8196
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Timepoint [1]
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These outcomes will be assessed at week 0, week 2 and week 4
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Secondary outcome [2]
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From a blood sample the role of markers of immune activation (cytokine production, and presence of activated, gut homing inflammatory cells) and/or genectic variables in predicting the response to therapy are obtained.
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Assessment method [2]
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Timepoint [2]
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Blood sample obtained at week 0 and week 4
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Secondary outcome [3]
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If a patient reports complete resolution of symptoms or near complete resolution of symptoms at week 4 they will be considered a responder and continue with placebo treatment until week 6. If at week 6 their symptoms have deteriorated they are considered relapsers. Relapsers do not require to complete week 8. Responders at week 6 continue with placebo treatment until week 8. If at week 8 they maintain complete resolution or near complete resolution of symptoms they are considered a placebo withdraw relapser otherwise they will be called a sustained responder.
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Assessment method [3]
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Timepoint [3]
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Assessment made at week 6 and week 8
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Eligibility
Key inclusion criteria
Patient meeting diagnostic criteria for Functional Dyspesia. Outpatients with a suspected diagnosis of functional dyspepsia based upon modified Rome III criteria.Sufficient understanding of English. Non Pregnant.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Non-consent. Insufficent English. Predominant reflux symptoms. Predominant Irritable Bowel Syndrome. Ongoing medication known to influence Gastrointestinal (GI) motility or acid secretion
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
480
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC) CAM Grant
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Address [1]
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Level5, 20 Allara Street
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital
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Address
Dr Jane Andrews
Gastroenterology Ward Q7
North Tce
Adelaide SA 5000
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Department of Health
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Address [1]
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11 Waymouth Street Adelaide SA 5000
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Adelaide Human Research Ethics Committee
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Ethics committee address [1]
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Royal Adelaide Hospital
Level 3 Hanson Institute
North Terrace
Adelaide SA 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/08/2008
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Approval date [1]
6024
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02/09/2008
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Ethics approval number [1]
6024
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080813
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Ethics committee name [2]
6025
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Repatriation General Hospital Human Research Ethics Committee
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Ethics committee address [2]
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Repatriation General Hospital
Daws Road,
Daw Park SA 5041
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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Ethics approval number [2]
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38/08
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Jane Andrews
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Address
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Royal Adelaide Hospital
Gastroenterology Ward Q7
North Terrace
Adelaide SA 5000
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Country
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Australia
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Phone
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088222 5207
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jane Andrews
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Address
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Gastroenterology Ward Q7
North Terrace
Adelaide SA 5000
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Country
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Australia
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Phone
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088222 5207
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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